[Ip-health] Re: Merck wants to produce EFV in Brazil

[michel lotrowska]

> Newspaper 'Valor Econômico' – September 8th 2008 (free translation)
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> Merck says that "issuing compulsory license" is something from the past a=
nd flags the local production
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> By André Vieira
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> Almost one year and a half after the adoption of the compulsory license f=
or Efavirenz, Merck Sharp & Dohme, the anti-retroviral producer, said that they have overcome the trauma of the compulsory license, resumed talks with the government and is willing to help to find a solution for the supply of the medicine that is part of the Aids cocktail.
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> "We want to find a solution ", says Merck's president for Latin America, =
José Tadeu Alves. According to him, the company has already overcome the property "expropriation". "This is something from the past. Even the government has changed its speech and we hope that it doesn´t do it again. This is another political moment."
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> In May 2007, the government signed a decreeissuing a compulsory license f=
or Efavirenz, considering its high price as a threat for the success of the Aids Programme. Later, the government started importing a generic version from India, while local production was being developed by public laboratories – Farmanguinhos and Lafepe. The production got delayed for technical problems. The budget proposal for the Aids Programme in 2009, which includes 185 thousand patients, is currently R$ 1,080 billion.
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> According to Tadeu Alves, Merck could guarantee again the supply of the m=
edicine both in terms of volume and in quality to fulfil the requests of the Aids Programme. "The government admits it will have to investment a lot for the production of EFAVIRENZ and knows that supplies from India are not reliable. ", he says.
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> For this reason, the laboratory is willing to collaborate with the govern=
ment. Merck says it cannot provide the medicine at the price paid for the imported tablet, of US$ 0,46. According to Tadeu Alves, this is under the company's cost of production. "We do not have the generic price, but we can find an adequate price."
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> For that, the manager says that Merck can produce Efavirenz locally in Ca=
mpinas (SP). "We have done previously a proposal, but it was not considered."
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> Efavirenz's raw material would be imported, but the company could reduce =
the cost by developing part of the process in the country. According to Merck's president, the investment would be low since the plant has idleness and is ready to produce it. The medicine could be put on the market in 180 days, he says. "We are going towards a collaboration. This is what I call a public and private partnership ", he says. Discussions have been taking place  with the Ministry of Health technical staff. "I have not talked to the Minister José Gomes Temporão."
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> If the result is positive, this kind of agreement with the government, ac=
cording to Tadeu Alves, could re-build Brazil' image in favour of intellectual property, affected by the the compulsory license of efavirenz.
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> The coordinator of the Brazilian Aids Programme, Mariângela Simão, sa=
ys that the generic imported by India is prequalified by the World Health Organization. Although there have been some problems with the local production of the medicine, it is now in a very advanced stage. "It is expected that the medicine will be distributed at the public health structures level during the first semester 2009", she says.
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> Mariângela Simão affirms that government is always open for negotiati=
ations. After the compulsory license, she says Merck kept offering the paediatric formulation of Efavirenz, maintained discussions with the government and obtained the registration for a new anti-Aids drug in the country, Raltegravir. "Technicians are evaluating the inclusion of this medicine in the programme, but we can negotiate with the company to have it produced in the country."
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